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NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid Tumors

Sponsor
Jiujiang University Affiliated Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04270461
Collaborator
KAEDI (Other)
0
Enrollment
1
Location
1
Arm
7
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and clinical activity of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.

Condition or Disease Intervention/Treatment Phase
  • Biological: NKG2D-based CAR T-cells
 Phase 1

Detailed Description

The preclinical study clarified that NKG2D-based CAR-T cells showed strong cytotoxicity against NKG2DL+ cell lines in vitro as well as a therapeutic effect against NKG2DL+ cell xenografts in vivo. In addition, the data also demonstrated the safety of NKG2D-based CAR-T therapy. NKG2D-based CAR-T represent a potentially effective and safety therapeutic approach for patient with relapsed/refractory NKG2DL+ solid tumors. In this trial, the investigators researched the safety of administering NKG2D-based CAR-T which generated with CD8 hinge region and transmembrane region, 4-1BB costimulatory region and CD3 zeta region. The investigators also assessed that disease response was determined within the context of a phase I trial.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Clinical Trial of NKG2D-based CAR T-cells Injection for Subjects With Relapsed/Refractory NKG2DL+ Solid Tumors
Actual Study Start Date :
Mar 17, 2020
Actual Primary Completion Date :
Oct 17, 2020
Actual Study Completion Date :
Oct 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arms

NKG2D-based CAR T-cells Injection; Dosage:1-10x10^6/kg, 70ml/time, The CAR-T cells will be administered by i.v. or hepatic portal artery injection over 20-30 minutes Frequency: total one time

Biological: NKG2D-based CAR T-cells
Autologous genetically modified anti-NKG2DLs CAR transduced T cells
Other Names:
  • KD-025 CAR T-cells

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability. [0 to 28 days post infusion]

      The severe CRS post KD-025 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.

    2. Copies numbers of CAR [1 year post infusion]

      Copies numbers of CAR in peripheral blood (PB)

    Secondary Outcome Measures

    1. overall survival (OS) [2 years post infusion]

      For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason

    2. Progress Free Survival (PFS) [2 years post infusion]

      Progress Free Survival after administration

    3. Duration of response, (DoR) [2 years post infusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria:

    1. Men or women≥18 years old,

    2. Patient with NKG2DL+ cell tumors confirmed by pathology and histology，

    3. Fail or unwilling to receive first-line treatment,

    4. Disease must be measurable according to the corresponding guidelines,

    5. Main organs function normally and meet following requirements:

    Routine blood index（No Blood transfusion within 14 days） 1)HB≥90g/L; 2)ANC≥1.5×109/L; 3)PLT≥75×109/L； Serum biochemicals index 1) BIL <1.5 upper normal limit (ULN); 2) ALT and AST<2.5×ULN; In the case of liver metastasis, ALT and AST<5×ULN; 3) Serum Cr≤1×ULN, endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula); 4) ECOG physical condition score: 0-2

    1. Expected survival time ≥3 months,

    2. Patient with adequate bone marrow reserve, hepatic and renal functions,

    3. No other uncontrolled diseases such as lung, kidney and liver infection before enrollment,

    4. Women of child-bearing age must undergo a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last dose; men should agree to contraception during the observation period and within 8 weeks of the last dose,

    5. Patients voluntarily participated in this trial and sign the informed consent form,

    6. Patients with compliance and expected to follow up the efficacy and adverse reactions as required by the protocol.

    Exclusion criteria:

    1. Pregnant or lactating women,

    2. Patients who need to use systemic steroids at the same time,

    3. Under following treatment conditions currently: 1) during the other anti- tumor clinical observation period within 14 days before blood collection; 2) patient has not recovered from acute side effects of the previous treatment;

    4. Receive radiotherapy within 4 weeks before enrollment,

    5. Patients who received any other cell therapy before,

    6. Patients with unqualified T cell amplification efficiency,

    7. Uncontrolled symptoms or other illnesses, including but not limited to infection, congestive heart failure, unstable angina, arrhythmia, psychosis,

    8. Patients with severe acute allergic reactions,

    9. Patients who have received other cell therapies,

    10. Other serious conditions that may limit patient's participation in the study.

    Detailed disease specific criteria exist and can be discussed with contacts listed below.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Affiliated hospital of jiujiang university Jiujiang Jiangxi China 332000

    Sponsors and Collaborators

    • Jiujiang University Affiliated Hospital
    • KAEDI

    Investigators

    • Study Director: Changchun Cai, Affiliated hospital of jiujiang university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiujiang University Affiliated Hospital
    ClinicalTrials.gov Identifier:
    NCT04270461
    Other Study ID Numbers:
    • JiujiangUH
    First Posted:
    Feb 17, 2020
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jiujiang University Affiliated Hospital
    NKG2D-based CAR T-cells
    solid tumors
    Additional relevant MeSH terms:
    Glioblastoma
    Medulloblastoma

    Study Results

    No Results Posted as of Oct 22, 2020